The event occurred in germany.It was reported that the rotaflow console did not displayed the flow measurement.The error message "com error" was displayed.In addition it was reported that the key tones were not audible and the lpm mode could not be selected.The failures occurred during the priming process.A getinge field service technician was onsite to investigate the rotaflow console with s/n (b)(6) on 2021-02-01.The technician could confirm the reported failure "flow measurement was not available", the error message "com error" and also the "key tones not audible".After the preventive replacement of the rfc control board kit ((b)(6)) the key tones were available and the device functioned as intended.The mentioned failure "lpm mode could not be selected" could not be reproduced by the technician.The replaced rfc control board kit ((b)(6)) has been requested for further investigation in our life cycle engineering (lce).The rfc control board kit was received on 2021-03-09 and investigated by the life-cycle-engineering (lce) on 2021-04-08.During the investigation the reported issue "key tones were not audible" could be confirmed, but it was deemed as no product related malfunction.Most probably the rota flow was used in combination with a hl 20 in a previous operation.Due to this the acoustic button feedback was deactivated on the rotaflow as the hl20 has the accustic alarm within this constellation.When the rotaflow is used back in stand alone mode the accustic alarm has to be reactivated as it would have the previous setting.Further reported failures could not be confirmed.According to the service manual | en | 02; chapter 8 error diagnosis the most probable root cause for the reported failure "com error" is "during the first seconds of the start up procedure, the message might be displayed, as the internal communication needs to be initialized." however, this notification will disappear after a few seconds.The reported failure "lpm mode could not be selected" is a result of the failure "no flow measurement in the lpm display".A probable root cause could be according the instructions for use rotaflow system| 4.2 | en | 13; chapter 5 preparing application 5.3 lpm/rpm mode "with a flow of less than 0.5 lpm it is not possible switch to lpm mode." the review of the non-conformities was performed on 2021-02-04 during the period of 2008-05-01 to 2021-02-04 does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences can be excluded.The product in question was produced in 2008-05-01.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.
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